Table 2

Treatment-emergent hypoglycemic events

Faster aspart (mealtime)Faster aspart (postmeal)IAsp (mealtime)
n%ERn%ERn%ER
Treatment-emergent hypoglycemia
 Severe*31.130.0283.180.0641.640.03
 Severe or BG confirmed22887.43,58327.9122788.03,59428.1521784.13,27625.66
 Daytime22686.63,18724.8222486.83,11724.4221784.12,96323.21
 Nocturnal11242.93963.0812548.44773.7410440.33132.45
Meal-related severe or BG-confirmed hypoglycemia
 Within 1 h after a meal6424.51190.934617.8660.526224.01050.82
 Within 2 h after a meal16161.77175.5813652.75053.9614757.06014.71
 Within 4 h after a meal20076.61,77713.8420177.91,78213.9619174.01,66813.07
  • Safety analysis set. %, percentage of participants; E, number of events; R, event rate per patient-year of exposure.

  • Treatment emergent was defined as an event that had onset up to 1 day after the last day of randomized treatment and excluding the events occurring in the run-in period. BG-confirmed hypoglycemia was defined as an episode with a plasma glucose value of <3.1 mmol/L (<56 mg/dL) with or without symptoms consistent with hypoglycemia.

  • *Severe according to ISPAD 2014.

  • †Nocturnal severe or BG-confirmed hypoglycemia was statistically significantly different in favor of mealtime IAsp vs. postmeal faster aspart (estimated rate ratio 1.50 [95% CI 1.09; 2.08], P = 0.014).